EP3403716B1 - Applicateur de ciment osseux doté du cylindre creux au niveau du piston de distribution - Google Patents

Applicateur de ciment osseux doté du cylindre creux au niveau du piston de distribution Download PDF

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Publication number
EP3403716B1
EP3403716B1 EP18170748.0A EP18170748A EP3403716B1 EP 3403716 B1 EP3403716 B1 EP 3403716B1 EP 18170748 A EP18170748 A EP 18170748A EP 3403716 B1 EP3403716 B1 EP 3403716B1
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EP
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Prior art keywords
cartridge
interior
monomer liquid
hollow cylinder
receptacle
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Application number
EP18170748.0A
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German (de)
English (en)
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EP3403716A1 (fr
Inventor
Sebastian Vogt
Thomas Kluge
Rainer Strathausen
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Heraeus Medical GmbH
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Heraeus Medical GmbH
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/32—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
    • B65D81/3233—Flexible containers disposed within rigid containers
    • B65D81/3238—Flexible containers disposed within rigid containers with additional means facilitating admixture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802—Equipment for handling bone cement or other fluid fillers
    • A61B17/8833—Osteosynthesis tools specially adapted for handling bone cement or fluid fillers; Means for supplying bone cement or fluid fillers to introducing tools, e.g. cartridge handling means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802—Equipment for handling bone cement or other fluid fillers
    • A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8822—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802—Equipment for handling bone cement or other fluid fillers
    • A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8825—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by syringe details
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802—Equipment for handling bone cement or other fluid fillers
    • A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8827—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it with filtering, degassing, venting or pressure relief means
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
    • B01F33/50—Movable or transportable mixing devices or plants
    • B01F33/501—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use
    • B01F33/5011—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use portable during use, e.g. hand-held
    • B01F33/50112—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use portable during use, e.g. hand-held of the syringe or cartridge type
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/71—Feed mechanisms
    • B01F35/713—Feed mechanisms comprising breaking packages or parts thereof, e.g. piercing or opening sealing elements between compartments or cartridges
    • B01F35/7131—Breaking or perforating packages, containers or vials
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/71—Feed mechanisms
    • B01F35/717—Feed mechanisms characterised by the means for feeding the components to the mixer
    • B01F35/7174—Feed mechanisms characterised by the means for feeding the components to the mixer using pistons, plungers or syringes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/75—Discharge mechanisms
    • B01F35/754—Discharge mechanisms characterised by the means for discharging the components from the mixer
    • B01F35/75425—Discharge mechanisms characterised by the means for discharging the components from the mixer using pistons or plungers
    • B01F35/754251—Discharge mechanisms characterised by the means for discharging the components from the mixer using pistons or plungers reciprocating in the mixing receptacle
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/32—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
    • B65D81/3233—Flexible containers disposed within rigid containers
    • B65D81/3244—Flexible containers disposed within rigid containers arranged parallel or concentrically and permitting simultaneous dispensing of the two materials without prior mixing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/32—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
    • B65D81/3255—Containers provided with a piston or a movable bottom, and permitting admixture within the container
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D83/00—Containers or packages with special means for dispensing contents
    • B65D83/0005—Containers or packages provided with a piston or with a movable bottom or partition having approximately the same section as the container
    • B65D83/0033—Containers or packages provided with a piston or with a movable bottom or partition having approximately the same section as the container the piston being a follower-piston and the dispensing means comprising a hand-operated pressure-device at the opposite part of the container
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00477—Coupling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00955—Material properties thermoplastic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802—Equipment for handling bone cement or other fluid fillers
    • A61B17/8833—Osteosynthesis tools specially adapted for handling bone cement or fluid fillers; Means for supplying bone cement or fluid fillers to introducing tools, e.g. cartridge handling means
    • A61B2017/8838—Osteosynthesis tools specially adapted for handling bone cement or fluid fillers; Means for supplying bone cement or fluid fillers to introducing tools, e.g. cartridge handling means for mixing bone cement or fluid fillers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F2101/00—Mixing characterised by the nature of the mixed materials or by the application field
    • B01F2101/20—Mixing of ingredients for bone cement

Definitions

  • the invention relates to a device for producing a bone cement dough from a monomer liquid and a cement powder as starting components of the bone cement dough and for discharging the mixed bone cement dough.
  • the invention also relates to a method for producing a bone cement dough, in particular a paste-like polymethyl methacrylate bone cement dough, with such a device.
  • the invention relates in particular to a device for storing the cement powder and the monomer liquid of polymethyl methacrylate bone cement separately, for subsequently mixing the cement powder with the monomer liquid to form a bone cement dough and for discharging the mixed bone cement dough.
  • the device according to the invention is preferably a full-prepacked cementing system.
  • PMMA bone cements go back to the fundamental work of Sir Charnley ( Charnley, J .: Anchorage of the femoral head prosthesis of the shaft of the femur. J. Bone Joint Surg. 42 (1960) 28-30 .).
  • Conventional polymethyl methacrylate bone cements (PMMA bone cements) are composed of a powder component and a liquid monomer component ( K.-D. Kühn: Bone cements for endoprosthetics: An up-to-date comparison of the physical and chemical properties of commercially available PMMA cements. Springer-Verlag Berlin Heidelberg New York, 2001 ).
  • the monomer component generally contains the monomer methyl methacrylate and an activator (N, N-dimethyl-p-toluidine) dissolved therein.
  • the powder component also referred to as cement powder or bone cement powder, has one or more polymers based on methyl methacrylate and comonomers such as styrene, methyl acrylate or similar monomers by polymerization, preferably suspension polymerization, an X-ray opaquer and the initiator dibenzoyl peroxide.
  • the powder component is mixed with the monomer component, the swelling of the polymers of the powder component in the methyl methacrylate results in a plastically deformable dough, the actual bone cement or bone cement dough.
  • the activator N N-dimethyl-p-toluidine reacts with dibenzoyl peroxide to form free radicals.
  • the radicals formed initiate the radical polymerization of the methyl methacrylate.
  • the viscosity of the bone cement paste increases until it solidifies.
  • PMMA bone cements can be mixed in suitable mixing cups with the aid of spatulas by mixing the cement powder with the monomer liquid. This can lead to the inclusion of air bubbles in the bone cement paste, which can negatively affect the mechanical properties of the hardened bone cement.
  • Cementing systems represent a further development in cementing technology in which both the cement powder and the monomer liquid are already packaged in separate compartments of the mixing devices and are only mixed with one another in the cementing system immediately before the cement is applied.
  • Such closed, full-prepacked mixing devices have been used with the EP 0 692 229 A1 , of the DE 10 2009 031 178 B3 , of the U.S. 5,997,544 A , of the US 6,709,149 B1 , of the DE 698 12 726 T2 , of the EP 0 796 653 A2 and the U.S. 5 588 745 A suggested.
  • the patent DE 10 2009 031 178 B3 discloses a storage and mixing device as a full-prepacked cementing system in which the starting components necessary for the production of the bone cement dough are already stored in the storage and mixing device and can be brought together and mixed in the storage and mixing device.
  • the storage and mixing device has a two-part discharge piston for closing a cement cartridge. A combination of a gas-permeable sterilization piston and a gas-impermeable sealing piston is used.
  • Polymethyl methacrylate bone cements are applied as bone cement dough after the cement powder has been mixed with the liquid monomer component in the not yet hardened, paste-like state.
  • the bone cement paste is in a cartridge in the case of powder-liquid cements.
  • the bone cement paste is pressed out of the cartridge by moving a discharge piston.
  • the discharge pistons usually have a diameter between 30 mm to 40 mm and thus an area of 7.0 cm 2 to 12.5 cm 2 on the outside on which a plunger or a rod of the extrusion device engages during the extrusion process.
  • the movement of the discharge piston is preferred by manually operated, mechanical ones Pressing out devices causes.
  • the US 2011/056984 A1 discloses an apparatus for mixing a dental adhesive in which a monomer liquid is pressed into a cement powder after breaking a thin part of a partition wall.
  • WO 00/35506 A1 A device is proposed in which polymethyl methacrylate cement powder is stored in a cartridge, the cement powder filling the entire volume of the cartridge and the spaces between the particles of the cement powder having a volume that corresponds to the volume of the monomer liquid used for the production of bone cement dough with the cement powder stored in the cartridge.
  • This device is constructed in such a way that the monomer liquid is introduced into the cartridge from above by the action of a vacuum, a vacuum being applied to a vacuum connection on the underside of the cartridge for this purpose. As a result, the monomer liquid is drawn through the cement powder, the air located in the interstices between the cement powder particles being displaced by the monomer liquid. Mechanical mixing of the cement dough formed with a stirrer is dispensed with.
  • the disadvantage of this system is that cement powder that swells quickly with the monomer liquid cannot be mixed with this device because the rapidly swelling cement powder particles form a gel-like barrier after the monomer liquid has penetrated the cement powder by about 1 to 2 cm and the migration impede the monomer liquid through all of the cement powder.
  • Conventional cement powders also show the phenomenon that due to the different Surface energies the cement powder particles are poorly wetted by methyl methacrylate. As a result, the methyl methacrylate penetrates the cement powder only relatively slowly. Furthermore, when a vacuum is applied, it cannot be ruled out that after the monomer liquid has completely penetrated the cement powder, the monomer liquid will be sucked off via the vacuum connection.
  • Electrically driven extrusion devices are also known from the area of adhesives and sealants. These devices can be powered both with accumulators and with batteries as well as with the help of a stationary power supply. With their sometimes very high pressing forces, these devices can press out particularly tough paste-like masses. However, it is disadvantageous when using electric motors that they contain non-ferrous metals and are cost-intensive to procure. In the operating theater area, which is to be kept sterile, such devices have to be sterilized or even replaced in a complex manner. With electrical cabling, the movement of the user in the operating room can be hindered.
  • Pneumatic devices have also been proposed. These devices require a stationary or mobile compressed air connection ( U.S. 2,446,501 A , DE 20 2005 010 206 U1 ). This requires compressed air hoses, which can hinder the user's movement.
  • pressurized gas cartridges can also be used to provide pressurized gas.
  • devices have been proposed in which the flow of pressurized gas is controlled by a valve and the flow of the viscous mass is also controlled by a second valve ( US 2004/0074927 A1 , US 6,935,541 B1 ).
  • the gas cartridges are integrated in the devices.
  • a pressurized gas source is always required, without which the systems can no longer be used.
  • the bone cement dough produced with this device always has a good consistency when using a suitable cement powder and a suitable weight ratio of cement powder to monomer liquid. If the bursting monomer liquid container is maximally compressed during the monomer transfer, a good cement paste is obtained in a reproducible manner. In certain constellations, however, there may be an undesirable change in the consistency of the bone cement paste at the end of the pressing process, in which the mixing ratio between the cement powder and the monomer liquid has changed. However, one to a few small monomer bubbles in the volume range of a few microliters can sometimes also appear at the edge of the pressed cement dough.
  • the object of the present invention is therefore to overcome the disadvantages of the prior art.
  • the object of the invention is to develop a device which is intended and suitable for mixing the bone cement dough from the starting components and for discharging the mixed bone cement dough, as well as a method for producing a bone cement dough, in particular a paste-like polymethyl methacrylate bone cement dough, the bone cement dough being made from a cement powder and a monomer liquid is produced with such a device with which the disadvantages of the previous devices and methods are overcome.
  • the object of the invention is to prevent the formation of monomer bubbles in the bone cement paste produced.
  • a further object of the present invention is to improve such a device in such a way that even if it is not complete Compression of the monomer liquid container at the end of the discharge of the bone cement paste, an escape of the monomer liquid from the discharge tube of the cartridge is effectively prevented.
  • the device according to the invention and the method according to the invention are thus intended to ensure that a homogeneous bone cement paste can be produced and applied from the beginning to the end of the extrusion process even with a very simple and inexpensive structure of the device and at the same time very simple and uncomplicated usability of the device. It is therefore the task of the not pre-published DE 10 2016 121 607 To improve the device described in such a way that the formation of the bone cement dough is reproducible without the stochastic occurrence of small monomer inclusions in the bone cement dough.
  • the device should be able to be driven by a simple press-out device and should be as simple as possible to operate.
  • the construction should be inexpensive so that the device can only be used once for hygienic reasons.
  • As many or all of the processes taking place in the device as possible, such as mixing the starting components, dispensing the bone cement paste and, if necessary, opening the monomer fluid container and possibly also opening the cartridge, should be automated with as few work steps as possible and as automated as possible, and preferably with it be driven by a single linear drive.
  • the object of the invention is therefore also to develop a device for mixing cement powder and monomer liquid.
  • the handling of the device should be simplified as much as possible in order to fundamentally avoid application errors as a result of incorrectly performed assembly steps.
  • the medical user should connect the device to an extrusion device after it has been removed from a packaging and then actuate it. Further assembly and work steps should be avoided by the structure of the device.
  • the device should preferably also enable safe storage of cement powder and monomer liquid in separate compartments, so that unintentional mixing of the cement components is excluded during storage of the device.
  • the device should enable sterilization with the gas ethylene oxide.
  • the cement powder stored in the device must be accessible to ethylene oxide for this purpose.
  • the device should be able to be activated with the help of an extrusion device that is manually driven in the operating theater, so that after the device is positively or non-positively connected to the extrusion device by actuating the extrusion device, the axially propellable rod of the extrusion device acts on the device, optionally opens the monomer liquid container and then further movement of the rod transfers the monomer liquid into the cement powder.
  • the mixing of the monomer liquid with the cement powder should be without a manually moved mixers from the outside. If possible, the mixing of the cement components with the formation of the bone cement paste and the pressing out of the mixed bone cement paste should be carried out only with the forward movement of the rod of the dispensing device. If possible, the opening of the monomer liquid container and the subsequent monomer liquid transfer into the cement powder should preferably only be carried out with the forward movement of the rod of the extrusion device.
  • a device for producing a bone cement dough from a monomer liquid and a cement powder as starting components of the bone cement dough and for discharging the mixed bone cement dough having a cartridge with a cylindrical interior, the interior of the cartridge on the front up to a discharge opening for expelling the bone cement dough is closed, a discharge piston that can be pushed in the direction of the discharge opening is arranged in the interior of the cartridge, and the cement powder is arranged in the interior of the cartridge between the discharge opening and the discharge piston, with a discharge piston on the front side facing the discharge opening Hollow cylinder is arranged, the hollow cylinder being open on its front side facing the discharge opening and extending from the front side of the discharge piston at least 3 mm into the interior of the cartridge corner, with at least one connection being provided in the discharge piston from the rear side of the discharge piston to the front side of the discharge piston for introducing the monomer liquid into the interior of the cartridge, the at least one connection being permeable to the monomer liquid and gases and impermeable to the
  • the discharge piston is tight or sealed against the inner wall of the interior of the cartridge, in particular is sealed with at least one circumferential seal.
  • the device according to the invention is preferably also provided for storing the cement powder and particularly preferably also provided for storing the monomer liquid.
  • the discharge opening is arranged in the front of the cartridge.
  • a discharge tube is or is arranged on the front of the cartridge, which delimits the discharge opening.
  • the hollow cylinder is arranged in the interior of the cartridge.
  • the fact that the hollow cylinder extends from the discharge piston in the direction of the front of the cartridge and thus in the interior of the cartridge means that a dead volume is limited by the hollow cylinder in the interior of the cartridge. Because a dead volume remains in the interior of the cartridge, a volume can remain between the discharge opening and the discharge piston which is filled with a mixture of the cement powder and the monomer liquid when the hollow cylinder is pressed against the front of the interior of the cartridge and the discharge piston as a result, it cannot be advanced further in the direction of the discharge opening.
  • the cartridge, the discharge piston and the hollow cylinder are preferably made from a thermoplastic, in particular using an injection molding process.
  • the interior of the cartridge has a cylindrical geometry.
  • the cylindrical shape is the simplest with which the interior of the cartridge can be realized.
  • a cylindrical shape is to be understood geometrically as the shape of a general cylinder with any base area, that is, not just a cylinder with a circular base area.
  • the inner wall of the interior of the cartridge can therefore be realized by the cylinder jacket of a cylinder with any base area, in particular with a different base area, that is to say also with non-circular or non-round base areas.
  • a cylindrical geometry with a rotationally symmetrical and in particular circular base area is preferred for the interior space, since this is the easiest to manufacture.
  • the front side of the discharge piston is preferably flat except for the hollow cylinder.
  • the hollow cylinder in devices according to the invention, provision can be made for the hollow cylinder to be spaced a maximum of 0.5 mm from the inner wall of the interior of the cartridge, preferably a maximum of 0.1 mm spaced from the interior wall of the interior of the cartridge.
  • the hollow cylinder rests at least in some areas on the inner wall of the interior of the cartridge, preferably on its outer jacket surface on the inner wall of the interior of the cartridge.
  • the hollow cylinder blocks further movement of the discharge piston in the direction of the front of the cartridge when the front of the hollow cylinder rests against the front of the interior of the cartridge, so that the discharge piston is spaced from the front of the interior of the cartridge and a Dead volume remains in the interior of the cartridge.
  • the hollow cylinder has at least one slot, preferably has at least one slot running parallel to the cylinder axis of the hollow cylinder, particularly preferably has at least one slot extending from the front side to the discharge piston.
  • the fit of the hollow cylinder to the inner wall of the cartridge can be adapted more easily and the risk of the movement of the discharge piston and the hollow cylinder being blocked is reduced.
  • the at least slot can also run in a spiral shape in the wall of the hollow cylinder.
  • At least one connection is provided in the discharge piston from the rear side of the discharge piston to the front side of the discharge piston for introducing the monomer liquid into the interior of the cartridge, the at least one connection being permeable to the monomer liquid and gases and impermeable to the cement powder and wherein the at least one connection from the discharge piston opens into the interior of the cartridge within the hollow cylinder or through lines in the hollow cylinder on the front side of the hollow cylinder.
  • the monomer liquid must first flow through the cement powder inside the hollow cylinder when it is passed through the bushing and inside the hollow cylinder and into the cement powder and cannot flow past the inner wall of the cartridge on the cement powder and thus reach the discharge opening.
  • the monomer liquid is passed through the lines in the hollow cylinder into the interior of the cartridge, it flows in an area closer to the center of the interior of the cartridge, so that the monomer liquid can spread from there in the direction of the discharge piston and is better distributed in the process.
  • the junction of the lines into the interior of the cartridge is preferably mounted in the area of the inner jacket of the hollow cylinder. This will ensures that the monomer liquid cannot flow by the shortest route to the inner wall of the interior of the cartridge. All of these measures serve to ensure that the bone cement dough produced and the bone cement dough discharged from the device have better homogeneity and that no, or as few as possible, inclusions of the monomer liquid are formed in the bone cement dough.
  • a further development of the present invention proposes that cement powder is contained, in particular pressed, in the part of the interior of the cartridge enclosed by the hollow cylinder.
  • the volume of the interior of the cartridge delimited by the hollow cylinder is at least 1 cm 3 , preferably at least 3 cm 3 .
  • the hollow cylinder extends from the front of the discharge piston at least 5 mm into the interior of the cartridge, preferably at least 7.5 mm into the interior of the cartridge, particularly preferably at least 10 mm into the Interior of the cartridge extends.
  • this increases the dead volume in the area enclosed by the hollow cylinder and, on the other hand, increases the path to the interface between the cement powder and the inner wall of the cartridge, which the monomer liquid has to travel through the cement powder before there is a risk that the monomer liquid will stick to the cement powder or can flow past bone cement dough that has already formed along the inner wall of the cartridge.
  • the wall thickness of the hollow cylinder is at least 1 mm, preferably at least 1.5 mm, particularly preferably at least 2 mm. This measure also serves to lengthen the path of the monomer liquid to the inner wall of the cartridge and thereby achieve greater homogeneity of the bone cement paste produced.
  • the hollow cylinder which is preferably made of plastic, is sufficiently stable so that it is not deformed or not deformed too much at the end of the extrusion process.
  • the device has a receptacle in which the monomer liquid, in particular a monomer liquid container containing the Monomer liquid, is contained, wherein the back of the cartridge is connected to the front of the receptacle, preferably is connected in such a way that the interior of the cartridge is aligned with the interior of the receptacle.
  • the device is also suitable for storing the monomer liquid and for mixing the monomer liquid with the cement powder within the device.
  • the device is thus a full-prepacked cementing system.
  • the aligned interiors of the cartridge and the receptacle ensure that the delivery piston can first be moved by a pressure acting on the rear side of the delivery piston and then the delivery piston can be used to drive the discharge piston by moving the delivery piston further in with the discharge piston Direction of the discharge opening is pressed.
  • the receptacle is preferably made from a thermoplastic plastic, in particular using an injection molding process.
  • the device can be manufactured inexpensively as a hygienic disposable product.
  • the monomer liquid in which the monomer liquid is arranged in a monomer liquid container within the device, it can be provided that the monomer liquid container is a glass ampoule, a plastic ampoule, a plastic film bag or an aluminum-plastic composite bag.
  • the monomer liquid can be stored for a particularly long time in such monomer liquid containers.
  • an interior of the receptacle and the interior of the cartridge are connected to one another via a connection which is permeable to the monomer liquid and gases but impermeable to the cement powder.
  • connection is particularly preferably arranged in the discharge piston.
  • the receptacle has a cylindrical interior space in which the monomer liquid, in particular a monomer liquid container containing the monomer liquid, is arranged.
  • the interior of the receptacle has a cylindrical geometry.
  • the cylindrical shape is the simplest with which the interior of the receptacle can be realized.
  • a cylindrical shape is to be understood geometrically as the shape of a general cylinder with any base area, that is, not just a cylinder with a circular base area.
  • a delivery piston which is movable in the longitudinal direction of the receptacle and which can be propelled from a rear side of the receptacle in the direction of the front side Discharge piston is arranged.
  • This provides a full-prepacked cementing system in which all the starting components of the bone cement paste, namely the monomer liquid and the cement powder, are contained and can also be stored there.
  • the delivery piston closes the receptacle on its rear side in a liquid-tight manner, except for any ventilation openings (see below).
  • At least one protruding point, edge and / or cutting edge for breaking the monomer liquid container is arranged on the front side of the delivery piston.
  • the pressure at this point can be increased with the same force and a defined breaking of the monomer liquid container can be achieved. This makes the process of breaking open the monomer liquid container more reproducible.
  • the monomer liquid container inside the receptacle is to be opened, preferably broken open or torn open, by a movement of the delivery piston in the direction of the front side of the receptacle.
  • an extrusion device with only one rod can be used as an axial linear drive in order to open the monomer liquid container as well as to press the monomer liquid into the cartridge and also to press the bone cement paste out of the cartridge.
  • At least one ventilation opening is arranged in the wall of the receptacle, which connects the interior of the receptacle with the surroundings.
  • the at least one ventilation opening is arranged so tightly in the area of the delivery piston that it is closed by a movement of the delivery piston in the direction of the front side of the receptacle before a monomer liquid container arranged in the receptacle, in which the monomer liquid is contained, is opened by the movement of the delivery piston.
  • the monomer liquid cannot escape from the interior of the receptacle when the at least one ventilation opening is closed by the delivery piston moving in the direction of the front of the receptacle before the monomer liquid container is opened by the movement of the delivery piston, for example by the delivery piston in the interior of the The recording is crushed, splintered or torn.
  • the receptacle and the cartridge are formed in one piece by a tubular container.
  • This structure is the simplest and most cost-effective structure to be implemented.
  • a fastening means for fastening an extrusion device is arranged on the rear side of the device, with which the discharge piston can be pressed in the direction of the discharge opening.
  • the device can be connected and fastened to an extrusion device with a rod that can be propelled.
  • the cement powder is in contact with the front side of the discharge piston, in particular over the entire surface, with the cement powder preferably being pressed into the interior of the cartridge.
  • the discharge opening is closed on its front side with a closure, in particular with a stopper, the bone cement paste being able to be pressed out of the cartridge through the discharge opening when the discharge opening is open, and the closure preferably being permeable to gases and is impermeable to the cement powder.
  • the cartridge can be used well for storing the cement powder.
  • the shutter can be opened.
  • the interior of the cartridge and the cement powder can be sterilized by evacuating and flushing the interior of the cartridge with a sterilizing gas, such as ethylene oxide, through the closure if the latter is permeable to gases and impermeable to the cement powder.
  • a sterilizing gas such as ethylene oxide
  • the closure is preferably a filter that is permeable to gases and impermeable to the cement powder, in particular a pore filter.
  • the closure has a recess on the rear side facing the interior of the cartridge, in which the foremost part of the cement powder is contained.
  • the closure preferably forms, with the discharge piston, a closure system of the cartridge that can be opened by means of axial pressure acting on the discharge piston in the direction of the discharge opening.
  • a dispensing tube is arranged on the front side of the cartridge, with the bone cement paste being able to be squeezed out through the dispensing tube.
  • the device can be used well for the application of bone cement dough in hard-to-reach places.
  • the volume of the intermediate spaces between the cement particles of the cement powder interior of the cartridge is in the range from 22 percent by volume to 40 percent by volume based on the total volume of the cement powder.
  • the total volume of the cement powder preferably corresponds to the volume of the interior of the cartridge, which is delimited by the discharge piston and by a closure in a discharge opening on the front of the cartridge.
  • Preferred devices according to the invention can also be characterized in that the cross section of the interior of the cartridge is a maximum of 16 cm 2 , preferably a maximum of 5 cm 2 .
  • the inside diameter of the cartridge is smaller than 50 mm, preferably smaller than 20 mm.
  • the cross-section of the interior of the cartridge is so small that the tough bone cement paste can be pressed out of the cartridge with the help of a manually driven extrusion device, even if there are other lines hindering the flow, such as a hose, an applicator tube or a static Mixers are provided in the flow direction of the bone cement paste.
  • the volume of the monomer liquid in the device is at least as large as the volume of the air-filled spaces between the cement powder particles in the cartridge, preferably at least as large as the volume of the liquid lines between the interior of the cartridge and the interior of a receptacle in which the monomer liquid is contained, plus the volume of the air-filled spaces between the cement powder particles in the cartridge. This can ensure that all of the cement powder can be wetted by the monomer liquid and a homogeneous bone cement paste is thus produced.
  • the hollow cylinder is designed in one piece with the discharge piston or with a part of the discharge piston resting against the inner wall of the cartridge.
  • the hollow cylinder and the discharge piston can be used as a one-piece component, which reduces the production costs.
  • the parts of the device can be made of plastic by injection molding.
  • step a) the monomer liquid is pressed into the cartridge through at least one connection in the discharge piston that is impermeable to the cement powder but permeable to gases and the monomer liquid or is pressed into the cartridge through the connection and at least one line in the hollow cylinder, is preferably pressed into the cartridge by a movement of a delivery piston which is driven by the rod of the ejection device.
  • step a) the device is first inserted into the extrusion device, then a delivery piston, which is movably mounted on the rear of the receptacle within a receptacle arranged on the rear of the cartridge, with the rod in the direction of the cartridge is driven forward, whereby a monomer liquid container in which the monomer liquid is contained is opened by the movement of the delivery piston and the monomer liquid is pressed from the receptacle into the cartridge, the cement powder mixing with the monomer liquid in the interior of the cartridge.
  • the method is also suitable for prior storage of the starting components. This allows the method to be used at any time using a compact, full-prepacked cementing system.
  • the delivery piston when the delivery piston is advanced, the broken or slashed or burst monomer liquid container is pushed together and at the same time gas is pressed from the receptacle through a connection into the cartridge and is pressed outwards by the cement powder in the cartridge.
  • step b) a closure, in particular a pore filter, is moved or pushed out in a discharge opening on the front of the cartridge by the pressure acting on the mixture of the cement powder with the monomer liquid, with the closure preferably being pushed out of the Discharge opening is removed and particularly preferably an application tube or a discharge tube extension is then attached to the front of the cartridge.
  • a closure in particular a pore filter
  • the contents of the cartridge can be sterilized with a sterilizing gas such as ethylene oxide.
  • the invention is based on the surprising finding that it is possible with the hollow cylinder on the front of the discharge piston to let the monomer liquid flow through the cement powder over a longer distance when it is pressed into the cement powder in the interior of the cartridge, or to conduct it before the monomer liquid hits the inner wall of the cartridge, and that thereby the formation of monomer liquid bubbles or inclusions of the monomer liquid in the bone cement dough formed can be avoided or reduced. This creates a more homogeneous bone cement paste.
  • the preferred device according to the invention in its further development as a full-prepacked cementing system has the essential advantages that the two starting components of the bone cement dough are stored in the closed cementing system and that the mixing of the starting components takes place in the closed device. This means that the device does not have to be filled by the user. The medical user has no contact whatsoever with the individual starting components of the bone cements. The unpleasant smell is therefore only minimal.
  • a special Another advantage of the device is that the monomer liquid is pressed into the cement powder by simply moving a rod of a manually driven extrusion device forwards. The air present between the cement powder particles is displaced by the monomer liquid. A homogeneous bone cement dough is created without manual mixing with mixing sticks with mixing blades being necessary. This means that the error-prone manual mixing is no longer necessary. The operation of the device is simplified to the maximum. It is a ready-to-use system.
  • the advantages of the devices and methods according to the invention are based in principle on the fact that the known linear forward movement of rods is used by manually operated extrusion devices in such a way that the continuous action of the force of the linear forward movement of the rod first opens a monomer liquid container and then compresses the monomer liquid container, whereby the monomer liquid exits the monomer liquid container and is pressed into compacted cement powder, the air present between the cement powder particles being displaced by the pressed-in monomer liquid and a bone cement paste being formed after the cement powder particles have been wetted by the monomer liquid.
  • the prerequisite for this is the use of a cement powder that is set so that it is very well wetted by the monomer liquid and can suck it in through capillary action.
  • the device can be used as a hygienic disposable product because it can be made largely of plastic and because all parts, including the interior spaces and the cement powder, can be sterilized with the aid of ethylene oxide.
  • the device according to the invention is characterized in that the occurrence of monomer bubbles in the pressed cement dough is effectively prevented if a hollow cylinder with an axial height of at least 3.0 mm and a wall thickness of at least on the discharge piston in the direction of the cartridge head or in the direction of the front of the cartridge 1.0 mm is attached.
  • the monomer liquid is introduced into the cement powder over a distance of at least 4.0 mm inside the hollow cylinder when the monomer liquid is introduced or pressed into the cement powder in the interior of the cartridge at the front of the discharge piston inside the hollow cylinder.
  • parts of the monomer liquid are effectively prevented from moving between the cement powder or the cement paste formed and the inner wall of the cartridge and from being able to form monomer bubbles.
  • the container comprises the cartridge as the front part of the container in which the cement powder is arranged, and a receptacle as the rear part of the container in which the monomer liquid container is arranged.
  • the hollow cylinder blocks the further movement of the discharge piston, a remainder of the mixture or the bone cement paste remains in the space in the interior of the cartridge that is delimited by the hollow cylinder.
  • FIGS 1 to 9 images of a device according to the invention are shown.
  • the Figures 1 to 3 and 5 and 6th show various schematic overall views of the exemplary device according to the invention.
  • the Figures 4 and 7 to 9 show schematic cross-sectional views as detailed views in the form of enlarged sections through different areas of the device according to the invention.
  • the device according to the invention consists essentially of a tubular plastic container which is inserted as the front part (in the Figures 1 and 2 above, in the Figures 3 , 4th , 7 to 9 left, in Figure 5 top right and in Figure 6 bottom left) forms a cartridge 1 with a cylindrical interior and which, as the rear part, forms a receptacle 2 for a glass ampoule 3 as a monomer liquid container.
  • a breakable plastic ampoule can also be used without further ado, or a tearable film bag made of a metal-coated plastic can be used instead of the glass ampoule 3 by minor modifications.
  • the back of the device is in the Figures 1 and 2 below, in the images of the Figure 3 right, in Figure 5 bottom left and in Figure 6 shown above right.
  • the tubular shape of the container is particularly good in the cross-sectional views of FIG Figures 1 , 3rd and 6th to recognize.
  • Both the interior of the cartridge 1 and the interior of the receptacle 2 are cylindrical with a circular base.
  • the diameter of the interior of the cartridge 1 and the diameter of the interior of the receptacle 2 are the same size and are aligned.
  • the container with the receptacle 2 and the cartridge 1 is preferably produced from plastic with the aid of an injection molding technique.
  • the receptacle 2 thus has a cylindrical interior into which the glass ampoule 3 is inserted.
  • the monomer liquid 4 is located in the glass ampoule 3 Figure 1 the device is shown upside down, so that gravity acts upwards and the monomer liquid 4 collects in the upper part of the glass ampoule 3.
  • a cement powder 5 is filled or preferably pressed into the interior of the cartridge 1.
  • the monomer liquid 4 and the cement powder 5 form the starting components for a PMMA bone cement which can be produced with the device. Because of the glass ampoule 3, the monomer liquid 4 can be stored for a very long time in the receptacle 2 and thus in the device.
  • the cement powder 5 can also be stored in the device for longer periods of time.
  • the device is thus suitable for storing the monomer liquid 4 and the cement powder 5 as starting components of a bone cement paste of the PMMA bone cement.
  • the device is also suitable and provided for mixing the bone cement dough from the starting components and for discharging the mixed bone cement dough.
  • a feed piston 6 made of plastic, which can be moved in the longitudinal direction in the cylindrical interior of the receptacle 2.
  • the delivery piston 6 is arranged in the area of the rear side of the receptacle 2.
  • the glass ampoule 3 can be pressed together with the delivery piston 6 in the receptacle 2 and thereby shattered, in that the delivery piston 6 is pressed in the direction of the front, that is, in the direction of the cartridge 1.
  • the delivery piston 6 has strippers on the front, with which splinters of the glass ampoule 3 are stripped from the inner wall of the receptacle 2. For this purpose, the wipers rest laterally on the inner wall of the interior of the receptacle 2.
  • a discharge piston 7 made of plastic is arranged in its rear side (in the Figures 1 and 2 Direction down, in the Figures 3 , 4th and 7 to 9 Direction to the right) in the interior of the cartridge 1 is in its rear side (in the Figures 1 and 2 Direction down, in the Figures 3 , 4th and 7 to 9 Direction to the right) a discharge piston 7 made of plastic is arranged.
  • a fastening means 8 is provided on the rear of the receptacle 2 with which the receptacle 2 can be attached to an extrusion device 43 (in Figure 1 and 2 not to see, see but Figure 3 ) can be connected.
  • the fastening means 8 is preferably suitable and provided for forming a bayonet lock 8.
  • the discharge piston 7 has a hollow cylinder 9 on its front side to lengthen the distance which the monomer liquid 4 must flow through the cement powder 5 until it reaches the inner wall of the cartridge 1.
  • the hollow cylinder 9 is used to space the Discharge piston 7 from a discharge opening on the front of the interior of the cartridge 1 and to create a dead volume between the discharge piston 7 and the front of the interior of the cartridge 1 when the discharge piston 7 or the hollow cylinder 9 is pressed against the front of the interior of the cartridge 1 to the maximum .
  • the hollow cylinder 9 is rotationally symmetrical and is shaped like a pipe section.
  • the hollow cylinder 9 can also have longitudinal sections running parallel to the cylinder axis of the hollow cylinder 9.
  • the hollow cylinder 9 is flat on the front side.
  • the hollow cylinder 9 is open on its front side facing the discharge opening.
  • a storage 12 made of foam is provided, which serves as a transport lock and as a shock protection for the glass ampoule 3. This is to prevent the glass ampoule 3 from breaking open unintentionally in the event of vibrations or impacts.
  • the foam and thus the storage 12 are permeable to gases.
  • the cartridge 1 and the receptacle 2 are made in one piece as a common plastic part.
  • the receptacle 2 and the cartridge 1 are connected to one another in a liquid-permeable manner for the monomer liquid 4 via a connection 14 in the discharge piston 7.
  • the connection 14 through the discharge piston 7 opens into the interior of the cartridge 1 through a pore filter 16 which is impermeable to the cement powder 5 but permeable to the monomer liquid 4.
  • a filter 18, with which the splinters of the glass ampoule 3 can be retained, is arranged in the discharge piston 7 at the confluence with the connection 14.
  • a sieve can also be provided.
  • Ventil openings 20 are provided in the wall of the receptacle 2, through which the interior of the receptacle 2 can be sterilized with the aid of a sterilizing gas such as ethylene oxide.
  • the bearing 12 is also gas-permeable and therefore does not close the ventilation openings 20.
  • the ventilation openings 20 are arranged directly adjacent to the delivery piston 6, so that the delivery piston 6 pushes itself directly in front of the ventilation openings 20 and thus closes the ventilation openings 20 immediately when the delivery piston 6 is in Direction of the cartridge 1 is advanced. This prevents the monomer liquid 4 from being able to escape through the ventilation openings 20 when the glass ampoule 3 in the receptacle 2 has been opened.
  • the cylindrical delivery piston 6 has an outer circumference that matches the cylinder geometry of the interior of the receptacle 2 and is sealed against the inner wall of the receptacle 2 in a liquid-tight manner by two circumferential seals 26.
  • the discharge piston 7 is also sealed against the inner wall of the cartridge 1 in a liquid-tight manner by means of two circumferential seals 28.
  • These seals 26, 28 serve to prevent monomer liquid 4 or bone cement from escaping in order to prevent contamination of the surroundings (of the operating room and the user).
  • the seals 26, 28 can consist of rubber for this purpose.
  • the interior of the cartridge 1 opens at the front into a discharge tube 34 which delimits the discharge opening of the cartridge 1.
  • the discharge tube 34 has an external thread at its base.
  • a pore filter 36 is arranged in the interior of the discharge tube 34 as a closure for the cartridge 1.
  • the pore filter 34 is impermeable to the cement powder 5 but permeable to gases.
  • a recess 37 is provided in the rear of the pore filter 36.
  • the cement powder 5 is also contained in the recess 37.
  • a cap 38 is attached to the external thread of the discharge pipe 34, the front part of the cap 38 being filled with a styrofoam or foam 40.
  • Two wings 42 are provided on the cap 38 so that the cap 38 can easily be unscrewed from the discharge tube 34 by hand in the manner of a wing screw.
  • the cap 38 has lateral openings 39.
  • the cement powder 5 is enclosed in the cartridge 1, since all the openings 39 and connections 14 are closed so as to be impermeable to the cement powder 5 with the aid of the pore filters 16, 36.
  • the contents of the cartridge 1 can be sterilized by evacuating and flushing with ethylene oxide. As a result, the device is also suitable for long-term storage of the cement powder 5.
  • the application tube 66 and the discharge tube extension 70 for the device are shown, which can be screwed onto the discharge tube 34 as an alternative to one another instead of the cap 38.
  • the application pipe 66 and the discharge pipe extension 70 have an internal thread that matches the external thread of the discharge pipe 34.
  • the discharge tube extension 70 can be closed with a closure 72.
  • the closure 72 ends in a handle 74 with which the discharge pipe extension 70 can be easily screwed onto the discharge pipe 34 by hand when the closure 72 is inserted in the discharge pipe extension 70.
  • the closure 72 which closes the side of the dispensing tube extension 70 facing the cartridge 1, can be conveniently removed with the handle 74, even if the dispensing tube extension 70 is firmly screwed to the dispensing tube 34.
  • Figure 3 shows four schematic cross-sectional views of the device according to the invention according to FIG Figures 1 and 2 one above the other to illustrate the sequence of a method according to the invention.
  • Figure 4 an enlarged section of the third illustration of Figure 3
  • Figure 7 an enlarged section of the second figure from the top of the Figure 3
  • Figure 8 an enlarged section of the fourth figure from the top of the Figure 3
  • Figure 9 an enlargement of the bottom figure of the Figure 3 .
  • the device is in its initial state, as it is in FIG Figure 1 is shown.
  • the device is inserted into an extrusion device 43, for example a conventional cartridge gun that can be driven by hand.
  • the extrusion device 43 comprises a rod 44 that can be linearly advanced. Only the front part of the extrusion device 43 is shown.
  • the extrusion device 43 also includes a handle and a rocker arm (not shown in the figures) for manually driving the rod 44 of the extrusion device 43, as in conventional manually powered extrusion devices.
  • the device is fastened to the extrusion device 43 with the fastening means 8 (see top figure in Figure 3 ).
  • a flat plate 46 for driving the delivery piston 6 is provided at the tip of the rod 44.
  • the rod 44 presses with the plate 46 on the delivery piston 6 when the rod 44 is pressed into the receptacle 2 by the extrusion device 43.
  • the extrusion device 43 is connected to the rear of the receptacle 2 via a counter-fastening means 48, so that the plate 46 presses on the delivery piston 6 when the rod 44 is advanced and drives it forward in the direction of the cartridge 1.
  • the rod 44 is mounted so as to be linearly movable against a bearing 50 and above it against the counter-fastening means 48 and thus against the receptacle 2.
  • the extrusion device 43 is operated and the rod 44 and, together with the rod 44, the delivery piston 6 are driven in the direction of the cartridge 1.
  • the delivery piston 6 closes the ventilation openings 20.
  • the bearing 12 is compressed and the delivery piston 6 hits the head of the glass ampoule 3. Since the glass ampoule 3 rests on the front side of the discharge piston 7 and the interior of the receptacle 2 continues reduced in size, the glass ampoule 3 is broken.
  • the monomer liquid 4 emerges from the glass ampoule 3 into the interior of the receptacle 2.
  • the discharge piston 7 cannot or cannot be pushed far from the glass ampoule 3 in the direction of the pore filter 36 when the cement powder 5 is dry, i.e.
  • the amount of the monomer liquid 4 is selected such that the cement powder 5 is wetted with the monomer liquid 4 up to the foremost tip of the cartridge 1, that is to say up to the recess 37 in the pore filter 36.
  • This situation is in Figure 3 , third figure from above and in detail after Figure 8 shown.
  • the pore filter 36 is driven forward by the pressure acting on the mixture 54 due to the pressure on the discharge piston 7 and compresses the foam 40. If the pore filter 36 now slides forward, it is released from the outside visible to the user through the opening 39 in the cap 38.
  • the pore filter 36 preferably has a different color and / or brightness than the foam 40.
  • the foam 40 can be white and the pore filter 36 red.
  • the cap 38 with the pore filter 36 and the foam 40 is unscrewed and instead an extended discharge opening in the form of an applicator tube 66 or in the form of a discharge tube extension 70 is screwed onto the discharge tube 34 (see also Figure 5 and Figure 6 ).
  • the foremost part of the mixture 54 or the bone cement paste 54 which is located in the recess 37 of the pore filter 38, is removed with the cap 38 and the pore filter 36.
  • a potentially poorly mixed part of the bone cement dough 54 is removed and thus greater homogeneity of the available bone cement dough 54 is achieved.
  • the delivery piston 6, the shards 52 and the discharge piston 7 arranged in front of it are driven.
  • the bone cement paste 54 is then discharged from the cartridge 1 via the applicator tube 66.
  • the discharge piston 7 is driven forward with the rod 44 in the direction of the discharge tube 34 (see also the fourth illustration from above in FIG Figure 3 as well as the detailed view after Figure 9 ).
  • the bone cement dough 54 from the interior of the cartridge 1 is expelled through the discharge tube 34 and the applicator tube 66 and can be applied there or theoretically used for further processing.
  • the hollow cylinder 9 hits the cartridge head or the front side of the interior of the cartridge 1. Since the discharge piston 7 is blocked at the end of the extrusion process, the shards and splinters 52 of the glass ampoule 3 may be pushed through the splinters and splinters 52 acting increasing pressure are compressed even further and, in the process, further residues of the monomer liquid 4 are pressed out of the space between the discharge piston 7 and the delivery piston 6 into the front part of the cartridge 1. This can lead to a change in the composition of the bone cement paste 54, since the proportion of liquid monomer liquid 4 in the mixture 54 is increased.
  • the hollow cylinder 9 has a height of 3 mm, preferably 5 mm or greater, so that the distance created thereby ensures that the front side of the discharge piston 7 is spaced from the front side of the interior of the cartridge 1 when the discharge piston 7 is so pushed it far forward, as is possible with a manually driven extrusion device 43. This creates a dead volume in the interior of the cartridge 1, specifically in the area delimited by the hollow cylinder 9, which cannot be expelled from the cartridge 1 through the discharge opening and the discharge tube 34.
  • That part of the bone cement dough 54 which may contain too large a proportion of monomer liquid 4 is now located in this dead volume. Even if the pressing continues, no further bone cement dough 54 can be pressed out of the dead volume from the device. This structure ensures that no bone cement paste 54 with a changing consistency due to a changing composition can be applied with the device.
  • the openings 39 also serve as visual markers which can be used to determine when the device is ready for use.
  • the pore filter 36 When the pore filter 36 is pushed forward due to the pressure of the bone cement dough 54 and the styrofoam 40 in the cap 38 is compressed, the pore filter 36 becomes visible through the openings 39. As a result, the user can see that the bone cement dough 54 is ready mixed in the cartridge 1 and is therefore ready for use.
  • the user can unscrew the cap 38 with the pore filter 36 and screw the applicator tube 66 or the discharge tube extension 70 onto the discharge tube 34.
  • the discharge piston 7 can then be driven via the feed piston 6 with the rod 44, and thereby the bone cement dough 54 can be driven out of the cartridge 1 through the applicator tube 66 or the discharge tube extension 70.

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Claims (16)

  1. Dispositif de fabrication d'une pâte de ciment osseux (54) à partir d'un liquide de monomère (4) et d'une poudre de ciment (5) servant de composants de départ de la pâte de ciment osseux (54), et d'évacuation de la pâte de ciment osseux (54) mélangée, le dispositif présentant
    une cartouche (1) avec un espace intérieur cylindrique, dans lequel l'espace intérieur de la cartouche (1) est obturé sur un côté avant jusqu'à un orifice d'évacuation permettant d'expulser la pâte de ciment osseux (54), dans lequel un piston d'évacuation (7) pouvant être poussé en direction de l'orifice d'évacuation est disposé dans l'espace intérieur de la cartouche (1) et dans lequel la poudre de ciment (5) est disposée dans l'espace intérieur de la cartouche (1) entre l'orifice d'évacuation et le piston d'évacuation (7), dans lequel,
    un cylindre creux (9) est disposé sur un côté avant du piston d'évacuation (7) orienté vers l'orifice d'évacuation, dans lequel le cylindre creux (9) est ouvert sur son côté avant orienté vers l'orifice d'évacuation et s'étend d'au moins 3 mm dans l'espace intérieur de la cartouche (1), dans lequel au moins une liaison (14), partant du côté arrière du piston d'évacuation (7) jusqu'au côté avant du piston d'évacuation, est prévue dans le piston d'évacuation (7) pour l'approvisionnement du liquide de monomère (4) dans l'espace intérieur de la cartouche (1), dans lequel l'au moins une liaison (14) est perméable pour le liquide de monomère (4) et pour les gaz et ne laisse pas passer la poudre de ciment (5), et dans lequel l'au moins une liaison (14) débouche du piston d'évacuation (7) à l'intérieur du cylindre creux (9), ou débouche par des conduites dans le cylindre creux (9) sur le côté avant du cylindre creux (9) dans l'espace intérieur de la cartouche (1).
  2. Dispositif selon la revendication 1, caractérisé en ce que le cylindre creux (9) est espacé au niveau de sa surface d'enveloppe extérieure de la paroi intérieure de l'espace intérieur de la cartouche (1) d'au maximum 0,5 mm, de préférence, d'au maximum 0,1 mm de la paroi intérieure de l'espace intérieur de la cartouche (1).
  3. Dispositif selon la revendication 1, caractérisé en ce que
    le cylindre creux (9) est plaqué au moins par endroits contre la paroi intérieure de l'espace intérieur de la cartouche (1), est de préférence plaqué au niveau de sa surface d'enveloppe extérieure contre la paroi intérieure de l'espace intérieur de la cartouche (1).
  4. Dispositif selon l'une des revendications précédentes, caractérisé en ce que le cylindre creux (9) bloque un nouveau déplacement du piston d'évacuation (7) en direction du côté avant de la cartouche (1) lorsque le côté avant du cylindre creux (9) est plaqué contre le côté avant de l'espace intérieur de la cartouche (1), de sorte que le piston d'évacuation (7) est espacé par rapport au côté avant de l'espace intérieur de la cartouche (1) et qu'il reste un volume mort dans l'espace intérieur de la cartouche (1).
  5. Dispositif selon l'une des revendications précédentes, caractérisé en ce que le cylindre creux (9) présente au moins une fente, de préférence, présente au moins une fente s'étendant parallèlement par rapport à l'axe de cylindre du cylindre creux (9), de manière particulièrement préférée, présente au moins une fente allant du côté avant jusqu'au piston d'évacuation (7).
  6. Dispositif selon l'une des revendications précédentes, caractérisé en ce que de la poudre de ciment (5) est contenue dans la partie de l'espace intérieur de la cartouche (1) entourée par le cylindre creux (9), en particulier, est pressée à l'intérieur.
  7. Dispositif selon l'une des revendications précédentes, caractérisé en ce que le volume de l'espace intérieur de la cartouche (1) délimité par le cylindre creux (9) est d'une taille d'au moins 1 cm3, de préférence d'au moins 3 cm3.
  8. Dispositif selon l'une des revendications précédentes, caractérisé en ce que le cylindre creux (9) s'étend à partir du côté avant du piston d'évacuation (7) d'au moins 5 mm dans l'espace intérieur de la cartouche (1), s'étend de préférence d'au moins 7,5 mm dans l'espace intérieur de la cartouche (1), s'étend de manière particulièrement préférée d'au moins 10 mm dans l'espace intérieur de la cartouche (1), et/ou
    l'épaisseur de la paroi du cylindre creux (9) est d'au moins 1 mm, est de préférence d'au moins 1,5 mm, est de manière particulièrement préférée d'au moins 2 mm.
  9. Dispositif selon l'une des revendications précédentes, caractérisé en ce que le dispositif présente un réceptacle (2) dans lequel le liquide de monomère (4), notamment un récipient de liquide de monomère (3) contenant le liquide de monomère (4), est contenu, dans lequel le côté arrière de la cartouche (1) est relié avec le côté avant du réceptacle (2), de préférence relié de telle manière que l'espace intérieur de la cartouche (1) est aligné avec l'espace intérieur du réceptacle (2).
  10. Dispositif selon la revendication 9, caractérisé en ce
    qu'un espace intérieur du réceptacle (2) et que l'espace intérieur de la cartouche (1) sont reliés ensemble par le biais d'une liaison (14) perméable pour le liquide de monomère (4) et pour les gaz, mais ne laissant pas passer la poudre de ciment (5),
    que le réceptacle (2) présente un espace intérieur cylindrique dans lequel le liquide de monomère (4), notamment un récipient de liquide de monomère (3) contenant le liquide de monomère (4), est disposé,
    qu'un piston de transport (6) mobile dans la direction longitudinale du réceptacle (2) est disposé dans le réceptacle (2), qui peut être avancé en direction du côté avant par le côté arrière du réceptacle (2), dans lequel le liquide de monomère (4), notamment un récipient de liquide de monomère (3) contenant le liquide de monomère (4), est disposé entre le piston de transport (6) et le piston d'évacuation (7), et/ou
    qu'au moins un orifice d'aération (20) est disposé dans la paroi du réceptacle (2), qui relie l'espace intérieur du réceptacle (2) avec l'environnement, dans lequel l'au moins un orifice d'aération (20) est disposé tellement près de la zone du piston de transport (6) qu'il s'obture par un déplacement du piston de transport (6) en direction du côté avant du réceptacle (2) avant qu'un récipient de liquide de monomère (3) disposé dans le réceptacle, dans lequel est contenu le liquide de monomère (4), soit ouvert par le déplacement du piston de transport (6).
  11. Dispositif selon l'une des revendications précédentes, caractérisé en ce qu'un système de fixation (8) est disposé dans le coté arrière du dispositif, pour la fixation d'un dispositif d'expulsion par pressage (43) avec lequel le piston d'évacuation (7) peut être pressé en direction de l'orifice d'évacuation.
  12. Dispositif selon l'une des revendications précédentes, caractérisé en ce que l'orifice d'évacuation est fermé au niveau de son côté avant avec un dispositif de fermeture (36), notamment avec un bouchon (36), dans lequel la pâte de ciment osseux (54) peut être pressée hors de la cartouche (1) par l'orifice d'évacuation lorsque l'orifice d'évacuation est ouvert, et dans lequel, de préférence, le système de fermeture (36) est perméable pour les gaz et ne laisse pas passer la poudre de ciment (5), et dans lequel, de préférence,
    le système de fermeture (36) présente, dans le côté arrière orienté vers l'espace intérieur de la cartouche (1), une cavité (37) dans laquelle la partie la plus en avant de la poudre de ciment (5) est contenue.
  13. Dispositif selon l'une des revendications précédentes, caractérisé en ce que la section transversale de l'espace intérieur de la cartouche (1) est d'au maximum 16 cm2, de préférence au maximum de 5 cm2, et/ou le cylindre creux (9) est conçu en une seule pièce avec le piston d'évacuation (7) ou est formé avec une partie du piston d'évacuation (7) adjacente à la paroi intérieure de la cartouche (1).
  14. Procédé de fabrication d'une pâte de ciment osseux (54), notamment d'une pâte de ciment en poly méthyl méthacrylate (54) en forme de pâte, dans lequel la pâte de ciment osseux (54) est fabriquée à partir d'une poudre de ciment (5) et d'un liquide de monomère (4) avec un dispositif selon l'une des revendications précédentes, avec les étapes suivantes se déroulant l'une après l'autre :
    a) l'emploi du dispositif dans un dispositif d'expulsion par pressage (43), le dispositif d'expulsion par pressage (43) présentant une tige (44) pouvant avancer axialement,
    a1) l'avancée d'un piston de transport (6) avec la tige (44) en direction de la cartouche (1), qui est logé en étant mobile sur le côté arrière du réceptacle (2), à l'intérieur du réceptacle (2) disposée sur le côté arrière de la cartouche (1), dans lequel, par le déplacement du piston de transport (6), un récipient de liquide de monomère (3), dans lequel est contenu le liquide de monomère (4), est ouvert, et le pressage du liquide de monomère (4) dans l'espace intérieur de la cartouche (1) par le déplacement du piston de transport (6) de sorte que le liquide de monomère (4) se mélange à la poudre de ciment (5) dans l'espace intérieur de la cartouche (1), dans lequel le liquide de monomère (4) s'écoule autour du cylindre creux (9) avant qu'il n'atteigne la paroi intérieure de la cartouche (1),
    b) le piston d'évacuation (7) est avancé avec la tige (44) en direction de l'orifice d'évacuation de la cartouche (1), dans lequel, par le déplacement du piston d'évacuation (7), le mélange à base de poudre de ciment (5) et de liquide de monomère (4) est expulsé hors de la cartouche (1) sous forme de pâte de ciment osseux (64) hors du dispositif, et
    c) le côté avant du cylindre creux (9) rencontre le côté avant de l'espace intérieur de la cartouche (1), dans lequel un nouveau déplacement du piston d'évacuation (7) avec le cylindre creux (9) est bloqué en direction de l'orifice d'évacuation et une quantité résiduelle du mélange de la poudre de ciment (5) avec le liquide de monomère (4) reste dans une partie de l'espace intérieur de la cartouche (1) délimitée par le cylindre creux (9).
  15. Procédé selon la revendication 14, caractérisé en ce que dans l'étape a), le liquide de monomère (4) est pressé à travers au moins une liaison (14), ne laissant pas passer la poudre de ciment (5) mais perméable pour les gaz et le liquide de monomère (4), dans le piston d'évacuation (7) dans la cartouche (1) ou est pressé à travers la liaison (14) et au moins une conduite dans le cylindre creux (9) dans la cartouche (1), est pressé dans la cartouche (1) de préférence par un déplacement d'un piston de transport (6) qui est entraîné avec la tige (44) du dispositif d'expulsion par pressage (43).
  16. Procédé selon l'une des revendications 14 ou 15, caractérisé en ce que dans l'étape b), un système de fermeture (36), notamment un filtre poreux (36), est déplacé ou avancé dans un orifice d'évacuation sur le côté avant de la cartouche (1) par la pression agissant sur le mélange (54) de la poudre de ciment (5) avec le liquide de monomère (4), dans lequel, de préférence, suite à cela, le système de fermeture (36) est retiré de l'orifice d'évacuation et de manière particulièrement préférée, ensuite un tuyau d'application (66), ou un prolongement de tuyau d'évacuation (70), est fixé sur le côté avant de la cartouche (1).
EP18170748.0A 2017-05-17 2018-05-04 Applicateur de ciment osseux doté du cylindre creux au niveau du piston de distribution Active EP3403716B1 (fr)

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JP (1) JP6774083B2 (fr)
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EP4309774A1 (fr) 2022-07-19 2024-01-24 Heraeus Medical GmbH Dispositif et procédé de fourniture d'une pâte de ciment osseux

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EP4309774A1 (fr) 2022-07-19 2024-01-24 Heraeus Medical GmbH Dispositif et procédé de fourniture d'une pâte de ciment osseux

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AU2018203250A1 (en) 2018-12-06
DE102017110732B4 (de) 2021-01-28
DE102017110732A1 (de) 2018-11-22
JP2018192249A (ja) 2018-12-06
CN108945827A (zh) 2018-12-07
AU2018203250B2 (en) 2019-01-17
EP3403716A1 (fr) 2018-11-21
CA3003182A1 (fr) 2018-11-17
CA3003182C (fr) 2020-08-04
US20180333176A1 (en) 2018-11-22
US10987147B2 (en) 2021-04-27
CN108945827B (zh) 2020-04-03
JP6774083B2 (ja) 2020-10-21

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